This invention relates generally to ambulatory medical systems that are capable of having their control software modified via telemetry including replacement of program code (i.e. algorithms) that control how variable parameters are utilized. Preferred embodiments relate to implantable infusion pumps and external devices for communicating therewith.
Various ambulatory medical devices have been proposed and a number of such devices are commercially available. These devices include implantable infusion pumps, externally carried infusion pumps, implantable pacemakers, implantable defibrillators, implantable neural stimulators, implantable physiological sensors, externally carried physiologic sensors, and the like.
Implantable infusion pumps are generally configured to accept infusion commands from an external communication device. These commands are used to set program variables that are used in defining the quantity and/or timing that is used in supplying a drug to the patient. These commands are however, typically, incapable of changing or updating the program code, i.e. algorithm(s), that utilizes these variables. As such, after manufacturing and more particularly after implantation, the operation of these devices is typically fixed and immutable with the exception of the operational variances allowed and required by a current set of values assigned to programmable variables within the device.
U.S. Pat. No. 5,360,437, entitled xe2x80x9cImplantable Medical Device With Flexible Hardware Platformxe2x80x9d, to Thompson proposes an implantable medical device, and most particularly a pacemaker, that includes a non-volatile ferroelectric random access read/write memory for storing microprocessor instructions that can be overwritten after the pacemaker is implanted so as to allow pacemaker functionality to be modified based on progressive or otherwise changing medical condition of the patient. The ""437 patent is focused on a providing a memory device that is non-volatile and that is capable of being written to.
The ""437 patent fails to address several considerations associated with reliable and safe modification of control software: (1) ensuring that newly downloaded program software was not corrupted during download, (2) ensuring that the software can be downloaded in a safe manner that does not allow inappropriate operation of the implantable device during download, (3) ensuring that the downloaded software does not inadvertently overwrite any program that is associated with continued and reliable operation of the communications between the implantable device and the external communication device, (4) ensuring that upon system reset the device can be restarted in a safe mode without restarting operation of the medically active functions of the implantable device that may have become corrupted and could be dangerous to a patient, and (5) ensuring that newly downloaded software is not incompatible with any software that remains in the implantable medical device.
As such, a need exists in the field for ambulatory (e.g. implantable) devices that can not only accept updated values for variables that impact operation of the device but that can also accept modifications to its program (i.e. set of control instructions or algorithms) in a way that is safe, maintains the predictability of the software operating on the implantable device and maintains the integrity of the communication operations even if the download involves corrupted software. As such a need continues to exist in the art for implantable medical devices and communicators having enhanced reliability, enhanced functionality, and and/or enhanced safety features.
It is a first object of the invention to provide an implantable medical device capable of receiving program code by telemetry from an external communication device while ensuring that newly downloaded program code was not corrupted during download.
It is a second object of the invention to provide an implantable medical device capable of receiving a software program by telemetry from an external communication device while ensuring that the downloaded program is received in a manner that does not allow inappropriate operation of the implantable device during the download.
It is a third object of the invention to provide an implantable medical device capable of receiving a software program by telemetry from an external communication device while ensuring that the downloaded code does not inadvertently overwrite any program code that is associated with continued and reliable operation of the communications between the implantable device and the external communication device.
It is a fourth object of the invention to provide an implantable medical device capable of receiving program code by telemetry from an external communication device while ensuring that upon system reset the device is restarted in a safe mode without restarting operations of medically active functions.
It is a fifth object of the invention to provide an implantable medical device capable of receiving program code by telemetry from an external communication device while ensuring that newly downloaded software is not incompatible with any medically active software that remains in the implantable device.
Other objects and advantages of various aspects of the invention will be apparent to those of skill in the art upon review of the teachings herein. The various aspects of the invention set forth below as well as other aspects of the invention not specifically set forth below but ascertained from the teachings found herein, may address the above noted objects or other objects ascertained from the teachings herein individually or in various combinations. As such, it is intended that each aspect of the invention address at least one of the above noted objects or address some other object that will be apparent to one of skill in the art from a review of the teachings herein. It is not intended that all, or even a portion of these objects, necessarily be addressed by any single aspect of the invention even though that may be the case with regard to some aspects.
A first aspect of the invention provides a medical system that includes (a) an ambulatory medical device (MD) that includes MD electronic control circuitry that further includes at least one MD telemetry system and at least one MD processor that controls, at least in part, operation of the MD telemetry system and operation of the medical device, wherein the medical device is configured to provide a treatment to a body of a patient or to monitor a selected state of the body; and (b) a communication device (CD) that includes CD electronic control circuitry that further includes at least one CD telemetry system and at least one CD processor that controls, at least in part, operation of the CD telemetry system and operation of the communication device, wherein the CD telemetry system sends messages to or receives messages from the MD telemetry system, wherein the MD processor is software controlled, and wherein the medical device includes an infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system.
A second aspect of the invention provides a medical system that includes (a) an ambulatory medical device (MD) that includes MD electronic control circuitry that further includes at least one MD telemetry system and at least one MD processor that controls, at least in part, operation of the MD telemetry system and operation of the medical device, wherein the medical device is configured to provide a treatment to a body of a patient or to monitor a selected state of the body; and (b) a communication device (CD) that includes CD electronic control circuitry that further includes at least one CD telemetry system and at least one CD processor that controls, at least in part, operation of the CD telemetry system and operation of the communication device, wherein the CD telemetry system sends messages to or receives messages from the MD telemetry system, wherein the medical device includes an MD memory for holding an MD program and wherein the MD processor controls operation of the medical device, at least in part, according to a program held in the MD memory, and wherein a CD memory holds an MD program that may be downloaded to the medical device and then used to control, at least in part, the operation of medical device.
In a specific variation of the second aspect of the invention the system additionally includes a second device (SD) that includes (a) an SD user readable display; (b) an SD touch-sensitive input device; (c) an SD processor and an SD memory for receiving commands from the SD touch-sensitive input device and for controlling the SD display; and (d) an SD communication system, controlled by the SD processor, for sending signals to or receiving signals from the communication device via a CD communication system within the communication device that is compatible with the SD communication system. In a further variation the SD communication system includes an infrared communication system. In a further variation the MD program within the communication device was transferred from the second device to the communication device via the SD communication system.
A third aspect of the invention provides a medical system that includes (a) an ambulatory medical device (MD) that includes MD electronic control circuitry that further includes at least one MD telemetry system and at least one MD processor that controls, at least in part, operation of the MD telemetry system and operation of the medical device, wherein the medical device is configured to provide a treatment to a body of a patient or to monitor a selected state of the body; and (b) a communication device (CD) that includes CD electronic control circuitry that further includes at least one CD telemetry system and at least one CD processor that controls, at least in part, operation of the CD telemetry system and operation of the communication device, wherein the CD telemetry system sends messages to or receives messages from the MD telemetry system, wherein the MD processor controls, at least in part, operation of the medical device according to the program held in the MD memory, wherein a CD memory holds an MD program that may be downloaded to the medical device and then used to control, at least in part, the operation of medical device, and wherein at least a portion of the messages transferable to the medical device include patient definable parameters that can be used on a regular basis to modify the treatment or monitoring performed by the medical device.
A fourth aspect of the invention provides a medical system that includes (a) an ambulatory medical device (MD) that includes MD electronic control circuitry that further includes at least one MD telemetry system and at least one MD processor that controls, at least in part, operation of the MD telemetry system and operation of the medical device, wherein the medical device is configured to provide a treatment to a body of a patient or to monitor a selected state of the body; and (b) a communication device (CD) that includes CD electronic control circuitry that further includes at least one CD telemetry system and at least one CD processor that controls, at least in part, operation of the CD telemetry system and operation of the communication device, wherein the CD telemetry system sends messages to or receives messages from the MD telemetry system, wherein the medical device further includes an MD memory for holding an MD program that controls, at least in part, operation of the medical device, wherein the medical device is capable of executing a first type of software that allows communication with the communication device and also allows medically significant operations to occur, wherein the medical device is capable of executing a second type of software that allows communication with a communication device but does not allow medically significant operations to occur.
In a specific variation of the fourth aspect of the invention the second type of software includes bootloader software that executes upon powering up or resetting the medical device.
In an additional specific variation of the fourth aspect of the invention at least one of the following is provided: (1) the medical device is capable of receiving new software of the first type from a communication device when the medical device is executing the second type of software but not when executing the first type of software, (2) the medical device is capable of receiving new software of the second type from a communication device when the medical device is executing the second type of software but not when executing the first type of software, (3) the medical device is capable of receiving a first type of telemetry communication that includes at least a first message type, when the medical device is executing the second type of software and wherein the medical device is not capable of receiving the first type of telemetry communication when executing the first type of software, or (4) the medical device is capable of receiving a second type of telemetry communication that includes at least a second message type, when the medical device is executing the first type of software and wherein the medical device is not capable of receiving the second type of telemetry communication when executing the second type of software.
A fifth aspect of the invention provides a medical system that includes (a) an ambulatory medical device (MD) that includes MD electronic control circuitry that further includes at least one MD telemetry system and at least one MD processor that controls, at least in part, operation of the MD telemetry system and operation of the medical device, wherein the medical device is configured to provide a treatment to a body of a patient or to monitor a selected state of the body; and (b) a communication device (CD) that includes CD electronic control circuitry that further includes at least one CD telemetry system and at least one CD processor that controls, at least in part, operation of the CD telemetry system and operation of the communication device, wherein the CD telemetry system sends messages to or receives messages from the MD telemetry system, wherein the medical device includes an MD memory for holding an MD program, and wherein the MD processor, at least in part, controls operation of the medical device according to the program held in the MD memory, and wherein the medical device, after being reset, boots itself into an operational mode that allows telemetry communications related to down-loading an MD program.
In a specific variation of the fifth aspect of the invention after being reset, the medical device, operates in a first operational state and then in a second operational state wherein the medical device is initially placed in the first operational state that does not allow medically significant treatment or monitoring to occur and stays in that first operational state until a command from the communication device causes transfer of operation to the second state that allows medically relevant treatment to be made or monitoring activities to occur.
A sixth aspect of the invention provides a medical system that includes (a) an ambulatory medical device (MD) that includes MD electronic control circuitry that further includes at least one MD telemetry system and at least one MD processor that controls, at least in part, operation of the MD telemetry system and operation of the medical device, wherein the medical device is configured to provide a treatment to a body of a patient or to monitor a selected state of the body; and (b) a communication device (CD) that includes CD electronic control circuitry that further includes at least one CD telemetry system and at least one CD processor that controls, at least in part, operation of the CD telemetry system and operation of the communication device, wherein the CD telemetry system sends messages to or receives messages from the MD telemetry system, wherein the medical device includes an MD memory for holding an MD program, and wherein the MD processor, at least in part, controls the operation of the medical device, at least in part, according to the program held in the MD memory, and wherein the medical device is capable of receiving a software image, or data image, that is transferred using a plurality of messages.
In a specific variation of the sixth aspect of the invention each message of the plurality is sent with a validation code that is compared to a validation code that is derived, at least in part, from information received in the message, wherein the received and derived validation codes must appropriately compare for the received message to be considered valid. In a further variation a validation code for an entire image is transmitted and compared to a validation code that is derived, at least in part, from the received and stored image, wherein the received and derived validation codes must appropriately compare for the received image to be considered valid.
A seventh aspect of the invention provides a medical system that includes (a) an ambulatory medical device (MD) that includes MD electronic control circuitry that further includes at least one MD telemetry system and at least one MD processor that controls, at least in part, operation of the MD telemetry system and operation of the medical device, wherein the medical device is configured to provide a treatment to a body of a patient or to monitor a selected state of the body; and (b) a communication device (CD) that includes CD electronic control circuitry that further includes at least one CD telemetry system and at least one CD processor that controls, at least in part, operation of the CD telemetry system and operation of the communication device, wherein the CD telemetry system sends messages to or receives messages from the MD telemetry system, wherein the medical device includes an MD memory for holding an MD program, and wherein the MD processor, at least in part, controls operation of the medical device according to the program held in the MD memory, and wherein a validation code is downloaded from the CD telemetry system, is stored in the MD memory, and is compared to a validation code that is periodically derived from at least a portion of an image forming the MD program to ascertain whether integrity of the at least portion of the image is retained
Additional specific variations, provide the medical devices of each of the above aspects and above noted variations as implantable devices such as implantable infusion pumps, implantable physiological sensors, implantable stimulators, and the like, or external devices such subcutaneous delivery infusion pumps or sensors that ascertain a physiological parameter or parameters from subcutaneous tissue or from the skin of the patient. Such infusion pumps may dispense insulin, analgesics, neurological drugs, drugs for treating AIDS, drugs for treating chronic ailments or acute ailments. Sensors may be used to detect various physiological parameters such as hormone levels, insulin, pH, oxygen, other blood chemical constituent levels, and the like. The sensor may be of the electrochemical type, optical type, and may or may not be enzymatic in operation.
In even further variations of the above noted aspects, and above noted variations, one or more of the following is provided: (1) a first portion of the MD telemetry system is incorporated into the MD processor and a second portion of the MD telemetry system is external to the MD processor, (2) a first portion of the CD telemetry system is incorporated into the CD processor and a second portion of the CD telemetry system is external to the CD processor, (3) the MD processor includes an MD central processing unit and at least one other MD functional module, (4) the CD processor includes a CD central processing unit and at least one other CD functional module, (5) the MD electronic control circuitry includes at least one external MD functional module, other than a portion of the MD telemetry system, that is external to the MD processor, or (6) the CD electronic control circuitry includes at least one external CD functional module, other than a portion of the CD telemetry system, that is external to the CD processor.
Still additional aspects of the invention set forth method counterparts to the above system aspects as well as to other functional associations and relationships, and processes that have not been specifically set forth above but will be understood by those of skill in the art from a review of the teachings provided herein.
Further aspects of the invention will be understood by those of skill in the art upon reviewing the teachings herein. These other aspects of the invention may provide various combinations of the aspects presented above as well as provide other configurations, structures, functional relationships, and processes that have not been specifically set forth above.